BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION 1CC INS SYR 31X5/16

    MDR report key: 1063847 · Received June 19, 2008

    Report

    Report Number
    1915484-2008-00031
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 9, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH AN INSULIN SYRINGE. CUSTOMER REPORTS THAT THE CANNULA HAS BROKEN OFF RIGHT WHERE IT COMES OUT OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION 1CC INS SYR 31X5/16 INSULIN SYRINGE FMF TYCO HEALTHCARE/KENDALL 8881608040 817700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK